A Multi-Center, Prospective, Single Cohort, Post-Market Clinical Follow-Up (PMCF) Study to Assess Implant Survival After Insertion of Straumann® Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 10
- 主要终点
- Implant Survival Rate at 12 Months After Implant Placement
研究概览
简要总结
The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow treatment of patients with single tooth gaps of small dimensions in the lateral and central incisor positions in the mandible and in the lateral incisor positions in the maxilla. These positions are reduced-load-bearing compared to more posterior positions.
During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.
详细描述
This is a multi-center, prospective, single cohort, post-market clinical follow-up (PMCF) study. The total study duration for each patient should be 12 ± 1 months.
Straumann BLT implants Ø 2.9 mm will be placed in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement, followed by provisional prosthetic loading after 6 ± 2 weeks and by final prosthetic loading 4 ± 1 months after implant placements.
In total 7 visits per patient are scheduled in this study. Implant survival, PES, implant success, bone level changes and adverse events (AEs) will be assessed.
The investigational device is a CE-(Conformité Européenne, meaning European Conformity) marked product. Straumann BLT implants Ø 2.9 mm Roxolid SLActive (sand blasted, large grit, acid etched surface) are available in lengths of 10, 12 and 14 mm.
Four centers in Germany will participate. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed.
- •Patients must be males or females who are a minimum of 18 years of age.
- •Patients with a minimum of 4 weeks history of edentulism in the study area, minimal interdental space and in need of a single tooth replacement with a dental implant central and lateral incisors in the mandible and lateral incisors in the maxilla (Federation Dentaire Internationale (FDI) positions 12, 22, 31, 32, 41 or 42).
- •Presence of natural tooth or implants adjacent to the study implant position (single tooth gap).
- •Patients with complete soft tissue coverage of the socket at implant placement.
排除标准
- •Patients with inadequate bone volume and / or quality or metabolic bone disorder.
- •Patients with local root remnants.
- •Patients with inadequate wound healing capacity.
- •Patients with not completed maxillary and mandibular growth.
- •Patients with serious internal medical problems, uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders.
- •Patients with poor general state of health.
- •Patients with drug or alcohol abuse.
- •Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy.
- •Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.
- •A woman who is pregnant or planning to become pregnant at any point during the study duration.
结局指标
主要结局
Implant Survival Rate at 12 Months After Implant Placement
时间窗: 12 months after implant placement
A "surviving implant" is an implant stably inserted in the subject's jaw bone at the time of assessment.
次要结局
- Pink Esthetic Score (PES) at 6 Months After Implant Placement(6 months after implant placement)